FibromyalgiaNCT06118970
Reduced Ability to Make Decisions: a Study That Observe Differences in Patients With Fibromyalgia and Healthy Control
An observational study of Fibromyalgia, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
The literature has identified impairments in various cognitive functions, including learning, memory, attention, psychomotor speed, executive function, and working memory. However, only a few studies to date have investigated impairment in the decision-making process. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Neuropsychological tasks and self-report questionnaires
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- 5 May 2024to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Residents in Belgium and Brussels, individuals belonging to fibromyalgia patient associations (e.g. VLFP), patients being treated at the UZ hospital in brussels in brussels.
Who may be able to join
- Fibromyalgia syndrome (confirmed by a medical diagnosis);
- Able to understand English, Dutch or French;
- Signed an informed consent.
Who cannot join
- Other diagnoses (osteoarthritis, rheumatoid arthritis, post-cancer pain, as well as patients with primary psychiatric/neurological conditions or psychopathological disorders);
- History of substance abuse or pathological gambling;
- Color blindness;
- Not have pain currently or have a recent history of pain (ONLY FOR HEALTY CONTROL GROUP).
Trial locations and contacts
1 site in 1 country.
Zosia Goossens, PhD student contact
Belgium1 site, 1 recruiting
- Recruiting
Vrije Universiteit Brussel
Brussels, Brussels Capital, 1000
Steven Provyn, Professor, steven.provyn@vub.be
About this study
Official title: Impaired Decision-making Capacity in Patients Suffering From Fibromyalgia: a Cross-sectional Study
The literature has identified impairments in various cognitive functions, including learning, memory, attention, psychomotor speed, executive function, and working memory. However, only a few studies to date have investigated impairment in the decision-making process.
The aim of this study is to evaluate decision-making skills in a group of patients with fibromyalgia and compare these results with a group of healthy controls. Specifically, investigators will evaluate four hypotheses:
- Patients with fibromyalgia may show disadvantageous decision-making in contexts of emotional decision-making and may persevere more in their wrong choices. For this reason, investigators hypothesize that patients with fibromyalgia will more frequently choose the disadvantageous decks than the healthy control group in the Iowa Gambling Task.
- Secondly, investigators hypothesize that patients with fibromyalgia need more time to make their choice. Consistent with this hypothesis, researchers expect to find significant differences in the average time taken by the participant to make a choice in the Iowa Gambling Task.
- The third hypothesis is that patients with fibromyalgia may have greater difficulty inhibiting automatic responses, which may lead to longer reaction times in the Stroop task. Investigators also hypothesize that stimuli with negative emotional valence (related to the typical pain experience in fibromyalgia) may have a greater effect on patients with fibromyalgia than on healthy controls (longer reaction time in the emotional Stroop Task compared to healthy controls).
- Finally, investigators hypothesize that anxiety, depression, sleep quality, pain, decision-making style and social support may be related to worse performance in ability-based tasks.
- Conditions
- Fibromyalgia
- Being tested
- Neuropsychological tasks and self-report questionnaires
- Keywords
- Fibromyalgia, Decision making, Stroop task, Iowa gambling task
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological tasks and self-report questionnairesOther
Being a cross-sectional observational study, no intervention will be administered. Subjects will be assessed with neuropsychological tasks and self-report questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Patients with fibromyalgia syndrome | Patients with fibromyalgia will be recruited at the UZ hospital in Brussels, at local patient organisations (e.g. VLFP), at the Vrije Universiteit Brussel and via social media alerts.
This syndrome must be confirmed by a medical diagnosis. Participants should be able to understand English, Dutch or French, they must have signed an in-formed consent and they must be at least 18 years old. Patients with other diagnoses will be excluded from this study (e.g., osteoarthritis, rheumatoid arthritis, post-cancer pain, as well as patients with primary psychiatric/neurological conditions or psychopathological disorders). Subjects with a history of substance abuse or pathological gambling and individuals with color blindness will also be excluded. Receives: Other: Neuropsychological tasks and self-report questionnaires | |
| Healthy controls | Healthy controls will be recruited through the University of Brussels or through social media alerts. Their exclusion criteria included, in addition to those specified for the fibromyalgia group, those who were suffering from fibromyalgia or had a severe rheumatic illness. Subjects should not have pain currently or have a recent history of pain (within the past 3 months). Receives: Other: Neuropsychological tasks and self-report questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iowa gambling task (IGT)
This task is designed to assess cognitive function in emotional decision-making. It is a computerized decision-making task that involves uncertainty, risk assessment, and the evaluation of both reinforcement and punishment.
Measured: Baseline (cross sectional)
Secondary outcomes (1)
Stroop task and Emotional Stroop task
The Stroop test is an instrument for assessing executive functions and aims to measure an individual's ability for selective attention, cognitive flexibility, and inhibition of automatic answers.
The Stroop task can also be manipulated to examine how emotional stimuli disrupt colour-naming performance (Emotional Stroop task).
Measured: Baseline (cross sectional)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start5 May 2024
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Polli, Vrije Universiteit Brussel
- Investigators
- Andrea Polli, Researcher, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118970
- Sponsor's protocol ID
- DeMa_FM_P01
- Status last verified
- May 2024
- First submitted
- 31 Oct 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vecchio E, Lombardi R, Paolini M, Libro G, Delussi M, Ricci K, Quitadamo SG, Gentile E, Girolamo F, Iannone F, Lauria G, de Tommaso M. Peripheral and central nervous system correlates in fibromyalgia. Eur J Pain. 2020 Sep;24(8):1537-1547. doi: 10.1002/ejp.1607. Epub 2020 Jun 16.
PubMed 32478943Wu YL, Huang CJ, Fang SC, Ko LH, Tsai PS. Cognitive Impairment in Fibromyalgia: A Meta-Analysis of Case-Control Studies. Psychosom Med. 2018 Jun;80(5):432-438. doi: 10.1097/PSY.0000000000000575.
PubMed 29528888Alfeo F, Decarolis D, Clemente L, Delussi M, de Tommaso M, Curci A, Lanciano T. Decision Making and Fibromyalgia: A Systematic Review. Brain Sci. 2022 Oct 27;12(11):1452. doi: 10.3390/brainsci12111452.
PubMed 36358377Walteros C, Sanchez-Navarro JP, Munoz MA, Martinez-Selva JM, Chialvo D, Montoya P. Altered associative learning and emotional decision making in fibromyalgia. J Psychosom Res. 2011 Mar;70(3):294-301. doi: 10.1016/j.jpsychores.2010.07.013.
PubMed 21334501Cuevas-Toro AM, Lopez-Torrecillas F, Diaz-Batanero MC, Perez-Marfil MN. Neuropsychological function, anxiety, depression and pain impact in fibromyalgia patients. Span J Psychol. 2014 Nov 14;17:E78. doi: 10.1017/sjp.2014.78.
PubMed 26054236Verdejo-Garcia A, Lopez-Torrecillas F, Calandre EP, Delgado-Rodriguez A, Bechara A. Executive function and decision-making in women with fibromyalgia. Arch Clin Neuropsychol. 2009 Feb;24(1):113-22. doi: 10.1093/arclin/acp014. Epub 2009 Mar 11.
PubMed 19395361Duschek S, Werner NS, Limbert N, Winkelmann A, Montoya P. Attentional bias toward negative information in patients with fibromyalgia syndrome. Pain Med. 2014 Apr;15(4):603-12. doi: 10.1111/pme.12360. Epub 2014 Jan 21.
PubMed 24447855Fischer-Jbali LR, Montoro CI, Montoya P, Halder W, Duschek S. Central nervous activity during an emotional Stroop task in fibromyalgia syndrome. Int J Psychophysiol. 2022 Jul;177:133-144. doi: 10.1016/j.ijpsycho.2022.05.009. Epub 2022 May 16.
PubMed 35588963Mercado F, Gonzalez JL, Barjola P, Fernandez-Sanchez M, Lopez-Lopez A, Alonso M, Gomez-Esquer F. Brain correlates of cognitive inhibition in fibromyalgia: emotional intrusion of symptom-related words. Int J Psychophysiol. 2013 May;88(2):182-92. doi: 10.1016/j.ijpsycho.2013.03.017. Epub 2013 Apr 2.
PubMed 23557844
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impaired Decision-making Capacity in Patients Suffering From Fibromyalgia: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06118970
- Acronym / sponsor ID
- DeMa_FM_P01
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Decision making, Stroop task, Iowa gambling task
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 5 May 2024 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The literature has identified impairments in various cognitive functions, including learning, memory, attention, psychomotor speed, executive function, and working memory. However, only a few studies to date have investigated impairment in the decision-making process.
The aim of this study is to evaluate decision-making skills in a group of patients with fibromyalgia and compare these results with a group of healthy controls. Specifically, investigators will evaluate four hypotheses:
- Patients with fibromyalgia may show disadvantageous decision-making in contexts of emotional decision-making and may persevere more in their wrong choices. For this reason, investigators hypothesize that patients with fibromyalgia will more frequently choose the disadvantageous decks than the healthy control group in the Iowa Gambling Task.
- Secondly, investigators hypothesize that patients with fibromyalgia need more time to make their choice. Consistent with this hypothesis, researchers expect to find significant differences in the average time taken by the participant to make a choice in the Iowa Gambling Task.
- The third hypothesis is that patients with fibromyalgia may have greater difficulty inhibiting automatic responses, which may lead to longer reaction times in the Stroop task. Investigators also hypothesize that stimuli with negative emotional valence (related to the typical pain experience in fibromyalgia) may have a greater effect on patients with fibromyalgia than on healthy controls (longer reaction time in the emotional Stroop Task compared to healthy controls).
- Finally, investigators hypothesize that anxiety, depression, sleep quality, pain, decision-making style and social support may be related to worse performance in ability-based tasks.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with fibromyalgia syndrome | – | Other: Neuropsychological tasks and self-report questionnairesPatients with fibromyalgia will be recruited at the UZ hospital in Brussels, at local patient organisations (e.g. VLFP), at the Vrije Universiteit Brussel and via social media alerts. This syndrome must be confirmed by a medical diagnosis. Participants should be able to understand English, Dutch or French, they must have signed an in-formed consent and they must be at least 18 years old. Patients with other diagnoses will be excluded from this study (e.g., osteoarthritis, rheumatoid arthritis, post-cancer pain, as well as patients with primary psychiatric/neurological conditions or psychopathological disorders). Subjects with a history of substance abuse or pathological gambling and individuals with color blindness will also be excluded. |
| Healthy controls | – | Other: Neuropsychological tasks and self-report questionnairesHealthy controls will be recruited through the University of Brussels or through social media alerts. Their exclusion criteria included, in addition to those specified for the fibromyalgia group, those who were suffering from fibromyalgia or had a severe rheumatic illness. Subjects should not have pain currently or have a recent history of pain (within the past 3 months). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents in Belgium and Brussels, individuals belonging to fibromyalgia patient associations (e.g. VLFP), patients being treated at the UZ hospital in brussels in brussels.
Key inclusion criteria (3 listed)
- Fibromyalgia syndrome (confirmed by a medical diagnosis);
- Able to understand English, Dutch or French;
- Signed an informed consent.
Key exclusion criteria (4 listed)
- Other diagnoses (osteoarthritis, rheumatoid arthritis, post-cancer pain, as well as patients with primary psychiatric/neurological conditions or psychopathological disorders);
- History of substance abuse or pathological gambling;
- Color blindness;
- Not have pain currently or have a recent history of pain (ONLY FOR HEALTY CONTROL GROUP).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological tasks and self-report questionnairesBeing a cross-sectional observational study, no intervention will be administered. Subjects will be assessed with neuropsychological tasks and self-report questionnaires. | Other | Healthy controls, Patients with fibromyalgia syndrome |
Primary outcome
Iowa gambling task (IGT)
Time frame: Baseline (cross sectional)
This task is designed to assess cognitive function in emotional decision-making. It is a computerized decision-making task that involves uncertainty, risk assessment, and the evaluation of both reinforcement and punishment.
1 secondary outcome
Stroop task and Emotional Stroop task
Time frame: Baseline (cross sectional)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 32478943Vecchio E, Lombardi R, Paolini M, Libro G, Delussi M, Ricci K, Quitadamo SG, Gentile E, Girolamo F, Iannone F, Lauria G, de Tommaso M. Peripheral and central nervous system correlates in fibromyalgia. Eur J Pain. 2020 Sep;24(8):1537-1547. doi: 10.1002/ejp.1607. Epub 2020 Jun 16.
- Background: PubMed 29528888Wu YL, Huang CJ, Fang SC, Ko LH, Tsai PS. Cognitive Impairment in Fibromyalgia: A Meta-Analysis of Case-Control Studies. Psychosom Med. 2018 Jun;80(5):432-438. doi: 10.1097/PSY.0000000000000575.
- Background: PubMed 36358377Alfeo F, Decarolis D, Clemente L, Delussi M, de Tommaso M, Curci A, Lanciano T. Decision Making and Fibromyalgia: A Systematic Review. Brain Sci. 2022 Oct 27;12(11):1452. doi: 10.3390/brainsci12111452.
- Background: PubMed 21334501Walteros C, Sanchez-Navarro JP, Munoz MA, Martinez-Selva JM, Chialvo D, Montoya P. Altered associative learning and emotional decision making in fibromyalgia. J Psychosom Res. 2011 Mar;70(3):294-301. doi: 10.1016/j.jpsychores.2010.07.013.
- Background: PubMed 26054236Cuevas-Toro AM, Lopez-Torrecillas F, Diaz-Batanero MC, Perez-Marfil MN. Neuropsychological function, anxiety, depression and pain impact in fibromyalgia patients. Span J Psychol. 2014 Nov 14;17:E78. doi: 10.1017/sjp.2014.78.
- Background: PubMed 19395361Verdejo-Garcia A, Lopez-Torrecillas F, Calandre EP, Delgado-Rodriguez A, Bechara A. Executive function and decision-making in women with fibromyalgia. Arch Clin Neuropsychol. 2009 Feb;24(1):113-22. doi: 10.1093/arclin/acp014. Epub 2009 Mar 11.
- Background: PubMed 24447855Duschek S, Werner NS, Limbert N, Winkelmann A, Montoya P. Attentional bias toward negative information in patients with fibromyalgia syndrome. Pain Med. 2014 Apr;15(4):603-12. doi: 10.1111/pme.12360. Epub 2014 Jan 21.
- Background: PubMed 35588963Fischer-Jbali LR, Montoro CI, Montoya P, Halder W, Duschek S. Central nervous activity during an emotional Stroop task in fibromyalgia syndrome. Int J Psychophysiol. 2022 Jul;177:133-144. doi: 10.1016/j.ijpsycho.2022.05.009. Epub 2022 May 16.
- Background: PubMed 23557844Mercado F, Gonzalez JL, Barjola P, Fernandez-Sanchez M, Lopez-Lopez A, Alonso M, Gomez-Esquer F. Brain correlates of cognitive inhibition in fibromyalgia: emotional intrusion of symptom-related words. Int J Psychophysiol. 2013 May;88(2):182-92. doi: 10.1016/j.ijpsycho.2013.03.017. Epub 2013 Apr 2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zosia Goossens, PhD student contact
Andrea Polli, Researcher principal investigator
Vrije Universiteit Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Vrije Universiteit Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefano Garzonio, Msc student (00393496243671, stefano.garzonio@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iowa gambling task (IGT) (time frame: Baseline (cross sectional)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06118970, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.